Long-term Follow-up Study Designed to Evaluate the Relative Risk of Two Colonoscopy Schedules for Patients With Small Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00032344
Recruitment Status : Completed
First Posted : March 19, 2002
Last Update Posted : August 31, 2018
Information provided by:
VA Office of Research and Development

Brief Summary:

Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains high because most colorectal cancers are detected after there has been regional or distant spread, precluding curative surgical resection. With this in mind, screening strategies have been recommended for asymptomatic individuals which hope to reduce mortality from colon cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions. Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood tests has been advocated by the American Cancer Society. However, current screening will identify only 50% of patients who have adenomatous polyps. More sensitive tests for polyp detection, like colonoscopy, are costly, require extensive resources and are unlikely to be used for screening large populations. Ideal screening would identify patients with the highest risk of cancer and target more sensitive screening tests at this population. The identification of low cost, easily collectible risk factors which can be used to target patients for the more sensitive screening tests is the primary purpose of this study. Since a major segment of the veteran population is over the age of 50, there will be a substantial impact in reduction of both mortality and morbidity due to colon cancer and attendant cost savings to the VA for treatment if such risk factors can be identified.

Phase I is a cross-sectional study designed to identify risk factors for large (>1 cm) adenomatous polyps. Approximately 3200 asymptomatic subjects (age 50-75) have completed risk factor assessment, medical and dietary histories, and have undergone complete colonoscopy examination. This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group. Data at colonoscopy will characterize the prevalence, size and distribution of adenomatous polyps. This will permit an assessment of sensitivity of sigmoidoscopy in this population. In addition, tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity. The primary focus of Phase I is a risk factor analysis. A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps. A cohort consisting of a subgroup of polyp patients (large and small) and matched polyp-free controls will be tracked longitudinally to determine polyp occurrence/recurrence rates.

Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopies.

Phase III is an extension in follow-up of an additional five years, a total of ten years in all, to include all study patients. The primary focus will be on documenting long-term mortality and medical outcomes as well as occurrence/reoccurrence of neoplasia with special emphasis on ten-year cancer rates.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Colonoscopy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CSP #380 - Prospective Evaluation of Risk Factors for Large (> 1 CM) Colonic Adenomas in Asymptomatic Subjects
Study Start Date : October 1993
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Phase I - Cross-sectional; Phase II - 5 year follow-up; Phase III - 10 year follow-up
Procedure: Colonoscopy
Phase I - Cross-sectional; Phase II - 5 year follow-up; Phase III - 10 year follow-up

Primary Outcome Measures :
  1. Phase I: Risk factors include: family history; dietary; fat, fiber, calcium; alcohol history; tobacco use; physical activity; obesity; NSAID use; and, biomarkers: BRDU, PCNA [ Time Frame: Cross-sectional ]

Secondary Outcome Measures :
  1. Phase II: Colonoscopy outcomes to determine recurrence rates and compare surveillance strategies [ Time Frame: 5 years ]
  2. Phase III: Medical outcomes including mortality. Colonoscopy outcomes in subgroup of polyp free patient at baseline to determine long term risk. [ Time Frame: 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Study Complete

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00032344

United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97239-2964
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
United States, Vermont
VA Medical & Regional Office Center, White River
White River Junction, Vermont, United States, 05009-0001
Sponsors and Collaborators
US Department of Veterans Affairs
Study Chair: David Lieberman, MD VA Medical Center, Portland

Publications of Results:
Responsible Party: Lieberman, David - Study Chair, Department of Veterans Affairs Identifier: NCT00032344     History of Changes
Other Study ID Numbers: 380
First Posted: March 19, 2002    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by VA Office of Research and Development:
large (>1 cm) adenomas

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases